Class I - Dangerous
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
NeuroLogica
Class I - Dangerous
Potential for the anti-fall system of the device arm to fail.
Class I - Dangerous
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
Class I - Dangerous
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment
Class I - Dangerous
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Class I - Dangerous
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
Class I - Dangerous
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Class I - Dangerous
An image was obtained with over exposure during a Thorax examination using the AEC function.
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Class I - Dangerous
When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.